There have been no cases of certification by, contracting with or even offer given prior to contracting by the notified bodies – this was the result of the investigation of the Hungarian Office of Health Authorisation and Administrative Procedures, which was launched based on an article published by The Daily Telegraph at the end of October 2012.

In an article published by the British newspaper The Daily Telegraph, it was reported that certain conformity assessment bodies in several Eastern and South-Eastern European countries – including Hungary – are willing to produce conformity certificates for potentially dangerous medical products, which could then be released onto the markets of the European Union. The dangerous hip replacement introduced by the undercover reporters has been developed by healthcare professionals for the exact purposes of the investigation initiated by the newspaper. According to The Daily Telegraph, the prosthetic is similar to a type of hip replacement banned in the United Kingdom which authorities suspect causes poisoning after it is implanted.

Following the publication of the article, several countries mentioned – including Hungary as well – launched investigations and preliminary information suggested that there is no reason to assume that the Hungarian notified bodies have violated legislation regulating notification and certification procedures.

After the conclusion of the detailed investigation, the opinion of the Office of Health Authorisation and Administrative Procedures is that conformity assessment bodies were aware of the risks associated with the product and have provided information to the reports, disguised as clients, in accordance with legal provisions. There has been no case of certification, no contract has been signed and not even an offer preceding contracting has been given by the notified bodies due to the insufficient data about the device.

The Office of Health Authorisation and Administrative Procedures will send the report of the investigation to the notifying and competent authorities of Member States of the European Union, including the Medicines and Healthcare Products Regulatory Agency, which initiated the investigation.

Nevertheless, the State Secretariat for Healthcare welcomes the revision process of the European Union Directive on medical devices launched in autumn 2012 and finds this revision very important, since it aims at establishing a regulatory framework that will better guarantee the safety of medical devices.

(Ministry of Human Resources)